Cold isostatic pressing of hydrating calcium sulfate as a means to produce parenteral slow-release drug formulations

In the present study, cold isostatic pressing of hydrating biocompatible inorganic materials was used to encapsulate active substance in a highly dense microstructure of bioresorable/biodegradable material. This forms the basis in the NanoZolid® technology. It was shown that such microstructures can...

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Bibliographic Details
Published inJournal of drug delivery science and technology Vol. 46; pp. 482 - 489
Main Authors Grudén, S., Hassan, M., Axén, N.
Format Journal Article
LanguageEnglish
Published Elsevier B.V 01.08.2018
Subjects
Anti-cancer
Bioresorbable
Calcium sulfate
Controlled release
Local drug delivery
Medicin och hälsovetenskap
NanoZolid® technology
Bioresorbable
NanoZolid® technology
Local drug delivery
Anti-cancer
Controlled release
Calcium sulfate
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Summary:In the present study, cold isostatic pressing of hydrating biocompatible inorganic materials was used to encapsulate active substance in a highly dense microstructure of bioresorable/biodegradable material. This forms the basis in the NanoZolid® technology. It was shown that such microstructures can be used to produce slow-release parenteral formulations for long-term drug release. The described novel principle to produce slow-release depot powder formulations was explored to manufacture a water-solvable calcium sulfate formulation encapsulating the anti-androgen substance 2-hydroxyflutamide (2-HOF) in a microstructurally designed calcium sulfate matrix. The microstructure of the solidified depot consisted of a composite of porous and dense material providing a combination of faster and slower release features. By mixing the drug loaded powder, consisting of densified and non-densified granular components, with an aqueous sodium carboxymethyl cellulose solution, an injectable suspension was formulated, which is injectable and which solidifies in vivo as a result of the ability of calcium sulfate to solidify by hydration. The NanoZolid powder was characterised regarding pharmaceutical process parameters and the microstructure of the solidified formulation was evaluated with scanning electron microscopy and elemental mapping. The in vitro drug release was evaluated with a specially designed dissolution method with convection only at sampling occasions. [Display omitted]
ISSN:1773-2247
DOI:10.1016/j.jddst.2018.06.013